HealthyPhase 1SADNCT00803855

Study to Assess Safety, Tolerability and Pharmacokinetics After Single Doses of AZD1446 to Healthy Volunteers

A Phase 1 study testing AZD1446 in people with Healthy, run by AstraZeneca at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The primary purpose of this study is to assess the safety and tolerability of AZD1446 following single dose administration. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: AZD1446
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 110 participants
Where: 1 siteSweden
Study dates: Dec 2008to Apr 2009
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

physical healthy volunteers
weight between 50 to 100 kg and a body mass index (BMI) between 19 and 30 kg/m2

Who cannot join

History of any clinically significant disease or disorder.
History of severe allergy/hypersensitivity reactions

Trial locations and contacts

1 site in 1 country.

Sweden1 site

Research site
Huddinge

Other trials in Sweden

About this study

Official title: A Phase I, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Single Ascending Dose Study to Asses the Safety, Tolerability, Pharmacokinetics of AZD1446 Including an Open Food Effect Panel in Healthy Male and Non-Fertile Female Volunteers

The primary purpose of this study is to assess the safety and tolerability of AZD1446 following single dose administration.

Conditions: Healthy
Being tested: AZD1446
Keywords: single dose, pharmacokinetics, safety, healthy volunteers, food interaction, AZD1446

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AZD1446Drug
oral, single dose

Study groups in NCT00803855
Study group	Role	What they receive
AZD1446 Oral or placebo	Experimental	Single oral administration of AZD1446 or placebo Receives: Drug: AZD1446
AZD1446 Oral, with or without food	Experimental	Single oral administration of AZD1446 with or without food Receives: Drug: AZD1446

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety and tolerability of AZD1446 by assessment of serious adverse events, ECGs, vital signs and laboratory variables
Measured: From first to last visit

Secondary outcomes (2)

Determine the single ascending dose pharmacokinetics of AZD1446
Measured: PK sampling taken at defined timepoints during residential period
Determine the single dose of AZD1446 on food interaction
Measured: From first to last visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2008Apr 2009

First posted8 Dec 2008 (estimated)
Study startDec 2008
Primary completionApr 2009
Study completionApr 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Single group
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00803855
Sponsor's protocol ID: D1950C00001
Other IDs: EudraCT No.: 2008-006228-76
Acronym: SAD
Status last verified: May 2009
First submitted: 5 Dec 2008
Last updated: 15 May 2009
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 15 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Single Ascending Dose Study to Asses the Safety, Tolerability, Pharmacokinetics of AZD1446 Including an Open Food Effect Panel in Healthy Male and Non-Fertile Female Volunteers
ClinicalTrials.gov ID: NCT00803855
Acronym / sponsor ID: SAD / D1950C00001
Conditions: Healthy
Keywords: single dose, pharmacokinetics, safety, healthy volunteers, food interaction, AZD1446
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 110 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Dec 2008
Primary completion: Apr 2009 (actual)
Study completion: Apr 2009 (actual)
First posted: 8 Dec 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary purpose of this study is to assess the safety and tolerability of AZD1446 following single dose administration.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Single group
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
AZD1446 Oral or placebo	Experimental	Drug: AZD1446Single oral administration of AZD1446 or placebo
AZD1446 Oral, with or without food	Experimental	Drug: AZD1446Single oral administration of AZD1446 with or without food

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

physical healthy volunteers
weight between 50 to 100 kg and a body mass index (BMI) between 19 and 30 kg/m2

Key exclusion criteria (2 listed)

History of any clinically significant disease or disorder.
History of severe allergy/hypersensitivity reactions

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AZD1446oral, single dose	Drug	AZD1446 Oral or placebo, AZD1446 Oral, with or without food

Primary outcome

Safety and tolerability of AZD1446 by assessment of serious adverse events, ECGs, vital signs and laboratory variables
Time frame: From first to last visit

2 secondary outcomes

Determine the single ascending dose pharmacokinetics of AZD1446
Time frame: PK sampling taken at defined timepoints during residential period
Determine the single dose of AZD1446 on food interaction
Time frame: From first to last visit

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2009.

Related trials for Healthy

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Didier Meulien, MD, PhD, MSD study director

AstraZeneca Södertälje

Ingemar Bylesjö, MD, PhD principal investigator

AstraZeneca CPU Huddinge

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AZD1446 in people with Healthy, run by AstraZeneca at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability of AZD1446 by assessment of serious adverse events, ECGs, vital signs and laboratory variables (time frame: From first to last visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00803855.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2009.